MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 17.5X17.5CM CTN 10; DRESSING,WOUND,OCCLUSIVE

Model Number 66800280

Device Problems Loss of or Failure to Bond (1068); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that many pieces of the adhesive edge of the allevyn gentle border dressings come loose in several sizes.It sticks to the sink and the floor.This happened specially to the bottom and sides of the patches.It is unknown if a patient was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

All supplied information has been reviewed and we were unable to establish a relationship between the device and the reported event or to determine a root cause.Probable root causes may include storage temperature or component failure.No lot/batch number has been provided, therefore a review of the manufacturing records is not possible.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: ALLEVYN GENTLE BORDER 17.5X17.5CM CTN 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11490636
• MDR Text Key: 240025193
• Report Number: 8043484-2021-00579
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223463991
• UDI-Public: 05000223463991
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800280
• Device Catalogue Number: 66800273
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1